Bloomberg News

Intuitive ‘Watered Down’ Robot Training, Lawyer Says

By Joel Rosenblatt
April 16, 2013

Intuitive Surgical Inc. (ISRG:US) designed a
training program to win regulatory approval for its surgical
robots that was later “watered down” to get them into more
hospitals, a lawyer for a woman suing the company told a jury.

The lawyer, Richard Friedman, made his opening statement
today to jurors in state court in Port Orchard, Washington,
telling them the training Intuitive provided for the robotic
surgery was compromised by aggressive marketing, led to errors
in removing Fred Taylor’s prostate gland, and eventually caused
his death.

The case, brought by his widow, Josette Taylor, is the
first to go to trial of at least a dozen lawsuits filed against
Sunnyvale, California-based Intuitive since 2011 alleging
injuries tied to its da Vinci surgical system. The robots were
used in more than 300,000 U.S. operations last year.

Intuitive designed a training program to get U.S. Food and
Drug Administration approval for its robot that, starting in
2000, under Gene Nagel, the executive in charge of training and
development, was simplified, targeted less-skilled surgeons and
was “watered down so much that nobody’s ever failed -- ever,”
Friedman said.

This case is “about a medical device company that sought
to radically change the way medical devices are marketed to
doctors,” Friedman told jurors.

The device was so novel “that no one else knew how to use
it,” Friedman said. Doctors, the government and hospitals had
to look to Intuitive for expertise, he said. “At bottom this
case is about a betrayal of that trust -- and one family that
got hurt by that betrayal.”

Seven Hours

After seven hours of robotic surgery on Taylor in September
2008, complications developed and the physician, Scott Bildsten,
and other doctors turned to traditional surgery and then
emergency care to repair a rectal laceration. Taylor died in
August of heart failure resulting from injuries caused by
Intuitive’s inadequate training of Bildsten, Friedman said.

Intuitive’s robots, which cost about $1.5 million each, are
used in 1,371 U.S. hospitals, the company has said. The robots
and related products generated most of its $2.2 billion revenue (ISRG:US)
in 2012.

‘Literally Unplugged’

Allen Ruby, a lawyer representing Intuitive, told jurors
that on the day of Taylor’s surgery, the “only physical injury
that was suffered by Mr. Taylor” occurred after “the da Vinci
robotic system was literally unplugged and out of the way and
not in use.” The suit is “an attempt to blame Intuitive” and
its marketing “for something that happened after the robotic
surgery was completed,” Ruby said.

Ruby, who will continue his opening defense arguments
tomorrow, presented jurors with a timeline, including Taylor’s
Sept. 9, 2008, surgery, that he said will be referenced
throughout the trial.

“We believe that the way to tell how good Intuitive’s
product and training and warnings were, is to look at the
surgery that was done on Mr. Taylor,” Ruby said.

If Bildsten was “poorly trained, if he was ignorant, if he
was unwarned” then “we would expect to see consequences in the
surgery which is the subject of this lawsuit.”

Arguing that Taylor’s death of heart disease four years
after the prostate surgery wasn’t caused by the da Vinci,
Intuitive said in a court filing that Taylor’s lawyers concede
that before the surgery, Taylor had been diagnosed with
diabetes, coronary artery disease, hypertension and high
cholesterol. His treatment included bypass surgery in 2002.

Obese Patient

Taylor weighed 280 pounds and had a body-mass index of 39,
which Bildsten said made him obese, according to the filing.
Intuitive said it told Bildsten that for his early procedures
with the da Vinci -- at least the first four to six surgeries --
he should choose simple cases and patients with a low body-mass
index.

“We take legal claims seriously and trust in the legal
system as the appropriate place to resolve these disputes,”
Angela Wonson, a spokeswoman for Intuitive, said in an e-mailed
statement.

Bildsten, who had performed 100 successful prostatectomies
using a traditional procedure and hadn’t used the da Vinci
system on a patient without being supervised, failed in Taylor’s
surgery to create a watertight seal between the bladder and the
urethra when the prostate was removed, inflating Taylor’s
abdomen with carbon dioxide pressure which led to a stroke,
according to court filings.

Mechanical Arms

In robotic surgery, a doctor sits at console several feet
from the patient and peers into a high-definition display. Foot
pedals and hand controls maneuver mechanical arms equipped with
surgical tools, guided by a 3D camera that shows the work as it
is done inside a patient.

According to court filings, Bildsten said Intuitive’s
training didn’t inform him of the need to create the watertight
seal or warn of the risk of abdomen inflation. After reading
Food and Drug Administration documents about the “learning
curve to obtain basic competency” with the da Vinci system,
Bildsten said, “I believe I likely would not have agreed to
begin training on the robot had I been given this information,”
according to the filing.

Bildsten said Intuitive told him he could achieve “basic
competency” after two assisted surgeries, and that the company
did not tell him that consultants paid by Intuitive reported
that such proficiency couldn’t be reached “until twenty or more
operations were complete,” according to the filing.

Bildsten was “led to believe the training program was FDA
approved,” Friedman told the jury today.